Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection
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Purpose
The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug regimen followed by treatment interruption in people recently infected with HIV. This study will also compare the effects of a treatment regimen including treatment interruption with a treatment plan based on clinical indicators.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Tenofovir disoproxil fumarate/Emtricitabine Drug: Lopinavir/Ritonavir |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Randomized Clinical Trial to Evaluate the Efficacy and Safety of Short Course Antiretroviral Therapy for Acute or Recent HIV-1 Infection in Zimbabwe and the United States |
- Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
- Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome [ Time Frame: At Week 24 ] [ Designated as safety issue: Yes ]
- Viral Set Point [ Time Frame: Throughout study ] [ Designated as safety issue: No ]set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus
| Enrollment: | 16 |
| Study Start Date: | January 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment interruption
Oral Tenofovir disoproxil fumarate/Emtricitabine and Lopinavir/Ritonavir for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
|
Drug: Tenofovir disoproxil fumarate/Emtricitabine
300 mg Tenofovir disoproxil fumarate/ 200 mg emtricitabine tablet taken orally once daily
Other Name: TDF/FTC
Drug: Lopinavir/Ritonavir
Three 400 mg lopinavir/ 100 mg ritonavir soft gel capsules taken orally twice daily
Other Name: LPV/RTV
|
|
Experimental: CD4 T cell guided therapy
Anti Retroviral Therapy initiated when AIDS-defining illness occurs or if CD4 count is confirmed at less than 350 mm^3 at two separate, consecutive measurements
|
Drug: Tenofovir disoproxil fumarate/Emtricitabine
300 mg Tenofovir disoproxil fumarate/ 200 mg emtricitabine tablet taken orally once daily
Other Name: TDF/FTC
Drug: Lopinavir/Ritonavir
Three 400 mg lopinavir/ 100 mg ritonavir soft gel capsules taken orally twice daily
Other Name: LPV/RTV
|
Detailed Description:
About 6 months after infection, HIV viral load reaches a temporarily stable level known as virus set point. Virus set point is different for each patient and can be a predictor for disease progression. Preliminary studies indicate that early, short-term antiretroviral therapy (ART) given to people newly infected with HIV may lead to lower virus set points and preserved CD4 counts. However, the length of short-term treatment needed to balance the possible adverse effects of ART with the achievement of lower virus set point is not yet known. By lowering the virus set point and maintaining CD4 counts, the need for long-term ART may be postponed. The purpose of this study is to determine the safety and efficacy of a short course of ART on producing a lower virus set point in adults recently infected with HIV.
This study will last at least 28 weeks. Participants will be randomly assigned to one of two arms. Arm A will receive ART for 12 weeks as emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) daily and lopinavir/ritonavir (LPV/RTV) in tablet form twice daily. After 12 weeks, treatment will be interrupted unless the CD4 count is measured to be less than 350 cells/mm^3 on two consecutive occasions during treatment interruption. If that occurs therapy will be resumed. Participants in Arm B will receive no treatment until cluster of differentiation 4 (CD4) counts drop below 350 cells/mm^3, indicating ART is needed. Study visits will occur at study entry, at Weeks 2 and 4, and every 4 weeks thereafter. At each study visit, a physical exam, blood collection, and completion of an adherence questionnaire will occur. Participants are encouraged to enroll in a related substudy that will evaluate HIV viral load in genital secretions.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Acute or recent HIV-1 infection. More information about this criterion can be found in the protocol.
- CD4 count 500 cells/mm3 or greater
- No evidence of prior or current AIDS-defining illness
- No signs or symptoms of HIV infection or AIDS-defining illness that, in the opinion of the investigator, requires ART
- Willing to use acceptable forms of contraception
Exclusion Criteria:
- Prior treatment with any antiretroviral drug for more than 7 days
- Use of certain drugs within 21 days of study entry
- Prior receipt of investigational anti-HIV-1 vaccine
- Ongoing therapy with systemic corticosteroids, chemotherapeutic agents, nephrotoxic systemic agents, immunomodulatory treatments, or investigational agents
- Known allergy/sensitivity to study drugs or their formulations
- Current drug or alcohol use or abuse that, in the opinion of the investigator, may interfere with the study
- Serious medical or psychiatric illness that may interfere with the study
- Hepatitis B infected
- Pregnancy or breastfeeding
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00414518
| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| Zimbabwe | |
| University of Zimbabwe College of Health Sciences | |
| Harare, Zimbabwe | |
| Study Chair: | Michelle A. Barron, MD | Division of Infectious Disease, University of Colorado Health Sciences Center | |
| Study Chair: | Margaret Borok, MRCP | Department of Medicine, University of Zimbabwe |
More Information
Additional Information:
Publications:
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00414518 History of Changes |
| Obsolete Identifiers: | NCT00525070, NCT01030172 |
| Other Study ID Numbers: | 06-0757, P01AI055356 |
| Study First Received: | December 19, 2006 |
| Results First Received: | September 6, 2012 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Colorado, Denver:
|
Acute Infection Early HIV Infection Short-Term Antiretroviral Therapy |
Treatment Interruption Antiretroviral Drug (ARV) ART |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome Communicable Diseases HIV Infections Infection Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases Emtricitabine Lopinavir |
Ritonavir Tenofovir Tenofovir disoproxil Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015